Clinical Trial: Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia

Brief Summary: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the feasibility of the addition of nelarabine to modified multiagent Berlin-Frankfurt-Muenster-86 chemotherapy in patients with newly diagnosed T-cell acute lymphoblastic leukemia.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics and intracellular pharmacology of nelarabine in these patients.

OUTLINE: This is a pilot, multicenter study.

Prednisone Response Pre-Induction: All patients receive oral prednisone three times daily on days -7 to -1 and methotrexate intrathecally (IT) on day -7* of week 0. Good prednisone responders proceed to induction on regimen A. Poor prednisone responders proceed to induction on regimen C.

NOTE: *Patients who have received cytarabine IT within the week prior to study entry receive methotrexate IT on day -6.

Regimen A (good prednisone responders) (closed as of 2/27/03):

Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone three times daily on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; asparaginase intramuscularly (IM) on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.

If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Those patients with minimal residual disease (MRD) on day 36 proceed to regimen B.